ALK secures EU and Canada rights to Neffy anaphylaxis nasal spray for $145m

Anaphylaxis, a severe allergic reaction, can be triggered by insect stings, certain foods, and specific medications. The nasal spray Neffy, developed by ARS Pharmaceuticals, offers a needle-free option to treat this condition. Danish company ALK-Abelló has recently acquired the rights to Neffy for Europe, Canada, and other regions for $145 million in an upfront payment.

In the agreement announced on November 9, ARS Pharmaceuticals will retain rights to Neffy in the United States, Australia, New Zealand, Japan, and China. ALK-Abelló will handle the distribution in the remaining global markets. Following the announcement, ALK’s stock prices saw a 2.6% increase on November 11. The company currently holds a market capitalization of $36.8 billion.

Neffy stands out as the only approved nasal spray for severe allergic reactions, obtaining FDA approval in August 2023. The European Commission also granted market authorization for the spray, marketed under the name EURneffy.

The terms of the deal include ALK paying up to $320 million in milestone payments, along with tiered royalties. ARS will continue Neffy’s development and manufacturing while ALK will distribute the spray in the licensed territories. ALK plans to launch Neffy in Europe by 2025 and aims to submit a regulatory approval application in Canada by the end of the year.

Anaphylaxis typically results from an immediate and severe immune response to foreign substances, such as food, insect stings, or medications. Current treatments primarily involve injectable products like Mylan’s EpiPen (epinephrine injection), which have proven effective. However, ALK has pointed out the drawbacks of auto-injectors, particularly for patients with a fear of needles, which can lead to delayed treatment. Neffy offers a potentially more straightforward and user-friendly alternative to the EpiPen, which has faced substantial controversy over the years.

ALK projects that Neffy could achieve peak annual sales of around $332.8 million in their licensed territories. Additionally, GlobalData’s Pharma Intelligence Centre forecasts that US sales of Neffy could reach $585 million by 2030. Along with acquiring global licensing rights, ALK has also secured rights to future applications of the drug. ARS is planning a Phase IIb trial in 2025 to evaluate the spray’s effectiveness in treating acute urticaria flares.

Peter Halling, CEO of ALK, expressed optimism about Neffy’s potential to set a new standard in managing anaphylaxis. He acknowledged that changing long-standing medical practices might take time and emphasized maintaining a diverse portfolio to address various patient and prescriber needs.

In 2023, sales of Mylan’s EpiPen amounted to $442 million. EpiPen became part of Viatris, a spin-off company from Pfizer, in 2020. This year, Pfizer has faced supply issues along with competition from the first approved generic version of EpiPen by Teva Pharmaceuticals.